Lead Manufacturing Operator

Durham, NC
Full Time
Mid Level
Summary of Key Responsibilities: 
  • Operate manufacturing equipment and instruments.
  • Complete assigned tasks in a timely manner.
  • Conduct daily activities in an organized, efficient manner.
  • Perform simple, routine, complex, and critical operations.
  • Troubleshoot equipment issues, when necessary.
  • Ensure process equipment is appropriately maintained for operation.
  • Perform and document operations in accordance with cGMP’s.
  • Execute equipment qualification protocols and validation protocols.
  • Routinely draft and revise standard operating procedures and master batch records.
  • Recognize and initiate process deviations.
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
  • Communicate effectively, both in written and verbal formats.
  • Maintain training compliance.
  • Ensure a safe working environment for all staff.

Required Qualifications and Skills: 
  • A.A.S. in a scientific discipline, or equivalent experience preferred.
  • 3-5 years’ experience in a cGMP manufacturing environment is required.
  • Experience with semi-solids, creams, and gels is highly preferred
  • Experience training/mentoring staff is a MUST! No direct reports.
  • Must be able to work within and adapt to electronic systems.
  • Able to work in an intense, fast-paced work environment.
  • Able to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
  • Able to work independently and as part of a team.
  • Must be able to read, write and converse in English.
  • Must have a good working knowledge of MS Office (Outlook, Word and Excel).
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